银黄口服液制备过程中绿原酸含量稳定性考察  

Stability of Chlorogenic Acid Content in the Preparation Process of Yinhuang Oral Liquid

作　　者：冯倩 张洪亮 庄华青 沈庆国 孙艳 关永霞 张贵民 FENG Qian;ZHANG Hongliang;ZHUANG Huaqing;SHEN Qingguo;SUN Yan;GUAN Yongxia;ZHANG Guimin(Lunan Hope Pharmaceutical Co.,Ltd.,Linyi,Shandong,China 276006;State Key Laboratory of Generic Manufacture Technology of Chinese Traditional Medicine,Linyi,Shandong,China 276006)

机构地区：[1]鲁南厚普制药有限公司,山东临沂276006 [2]中药制药共性技术国家重点实验室,山东临沂276006

出　　处：《中国药业》2022年第3期71-75,共5页China Pharmaceuticals

基　　金：山东省重点研发计划(重大科技创新工程)项目[2020CXGC010505];山东省临沂市科技创新发展专项项目[2019ZDZX001];山东省临沂市兰山区科技发展计划项目[1942]。

摘　　要：目的考察银黄口服液制备过程中绿原酸含量的稳定性。方法在2015年版《中国药典(一部)》制剂制备工艺基础上,以药液pH、煎煮时间、灭菌方式为自变量,考察绿原酸的含量变化,并比较法定工艺与优选工艺制备的样品中绿原酸的含量;于温度(40±2)℃、相对湿度为(75±5)%环境下进行6个月加速试验,考察不同灭菌条件下制剂中绿原酸的含量变化及微生物限度。结果煎煮前调节药液pH至6.0,煎煮30 min,80℃水浴60 min灭菌后,制剂中绿原酸的含量最高;与法定工艺相比,此工艺下制备的制剂中绿原酸转移率提高了24.95%;80℃水浴60 min灭菌后制剂中微生物限度检验均合格。结论该工艺合理、可行,能有效提高银黄口服液中绿原酸的含量。Objective To investigate the stability of chlorogenic acid content in the preparation process of Yinhuang Oral Liquid.Methods Based on the preparation process of Yinhuang Oral Liquid in the Chinese Pharmacopoeia(2015 Edition,Volume I),the content changes of chlorogenic acid were investigated with the pH of drug liquid,decocting time and sterilization method as the independent variables,and the content of chlorogenic acid in the samples prepared by the statutory process and optimal process was compared.The accelerated test was carried out for six months with temperature of(40±2)℃ and relative humidity of(75±5)%to investigate the content change and microbial limit of chlorogenic acid in the preparation under different sterilization conditions.Results The pH of the drug liquid was adjusted to 6.0 before decocting.The content of chlorogenic acid in the preparation was the highest after decocting for 30 min and sterilizing in 80℃ water bath for 60 min.Compared with that in the preparation prepared by the statutory process,the transfer rate of chlorogenic acid in the preparation prepared by the optimal process was increased by 24.95%.After sterilization in 80℃ water bath for 60 min,the microbial limit test of the preparation was qualified.Conclusion The process is reasonable and feasible,which can effectively improve the content of chlorogenic acid in Yinhuang Oral Liquid.

关 键 词：银黄口服液 绿原酸 转移率 含量 稳定性 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学]